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Dibutyl sebacate
دیبوتیل سباکات
1Nonproprietary names
- USP–NFDibutyl Sebacate
2Synonyms and trade names
butyl sebacate; DBS; decanedioic acid dibutyl ester; dibutyl decanedioate
3Chemical name and CAS Registry Number
Dibutyl decanedioate · [109-43-3]
UNII 4W5IH7FLNY · PubChem CID 7986
4Empirical formula and molecular weight
C18H34O4 · 314.46
5Functional category
Plasticiser
Typical concentrations: — · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used as a plasticiser in film coatings for modified-release and enteric products, particularly with ethylcellulose and methacrylic acid copolymers, typically at about 10–30% of the polymer weight. It also plasticises polymers in other applications and is used as a flavouring in foods.
7Description
A clear, colourless, oily liquid with a faint odour.
8Typical properties
- Boiling point
- about 345 °C
- Melting point
- about −10 °C
- Specific gravity
- about 0.935–0.939 at 20 °C
- Solubility
- practically insoluble in water; soluble in ethanol, isopropyl alcohol, mineral oil and most organic solvents
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents. It can soften some rubbers and plastics.
11Method of manufacture
Made by esterifying sebacic acid, obtained from castor oil, with n-butanol in the presence of an acid catalyst, followed by purification by distillation.
12Safety
Of low toxicity and generally non-irritant at the levels used in pharmaceutical coatings and foods.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended.
14Regulatory status
Included in the FDA Inactive Ingredient Database (oral capsules and tablets, including modified-release forms). Used as a flavouring substance in foods.
15Related substances
Dibutyl phthalate; diethyl phthalate; triethyl citrate; tributyl citrate; acetyltributyl citrate.
16Comments
A common phthalate-free plasticiser. Because it is insoluble in water, it must be emulsified into aqueous polymer dispersions and given enough time to partition into the polymer particles before coating; coated products usually need curing to complete film formation.